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European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank (chILD-EU)

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ClinicalTrials.gov Identifier: NCT02852928
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : October 3, 2017
Information provided by (Responsible Party):
Matthias Griese, Ludwig-Maximilians - University of Munich

Brief Summary:
Generation of a common European database and biobank Continous assessment and implementation of guidelines and treatment protocols Establishment of a large observational cohort of chILD patients Determination the value of outcomes used in child Assess treatment variations used, deliver data from defined protocols and linked outcomes

Condition or disease
Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis Pulmonary Eosinophilia Pulmonary Fibrosis Respiratory Distress Syndrome, Newborn Child

Detailed Description:

Objective 1: Generation of a common European database and biobank. The existing national programmes to collect data on chILD in three countries (France, Germany, UK) will enable the consortium to swiftly adapt current frameworks to a functionally appropriate pan-European web-based database and biobank. Importantly, compatibility with ongoing United States chILD data base developments will be factored in.

Objective 2: Continuous assessment and implementation of guidelines and treatment protocols. Our Standards Working Group will convene regularly. Initial tasks will establish (a) specific diagnostic pathways, including detailed protocols for gathering clinical information, blood testing, imaging and pathology ("Best Practice Checklist"); (b) international panels of clinicians, geneticists, radiologists and pathologists who will review every diagnosis to quality control the data; and (c) detailed protocols for follow up to generate natural history data.

Objective 3: Recruitment of a carefully characterized cohort of chILD patients. European wide recruitment and interdisciplinary critical peer review of all diagnoses submitted from across Europe is imperative. Each case will be given a diagnosis independently; if no firm diagnosis is possible, we will review the case periodically as new information becomes available. During the first year of the study, clinicians´ decisions according to local practice and outcomes will be independently monitored and assessed.

Objective 4: Determine the value of outcomes used in chILD. We will systematically optimize and clarify the relative weight of a large spectrum of single and composite clinical outcomes (using both clinician and carer scoring), sequential limited chest CT (to minimise radiation exposure), lung function testing, histopathological categorization of lung biopsies, serum markers and genetic tests. Variability, reproducibility and the effects of training on reading images will be investigated.

Objective 5: Assess treatment variations used, deliver data from defined protocols and linked outcomes. This project will analyse in detail treatment and outcomes within and between subjects using data collected. Analysis of the collected data will enable us to support the definition of trial protocols planned in the future.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Orphans Unite: chILD Better Together - European Management Platform for Childhood Interstitial Lung Diseases / chILD-EU - International Register and Biobank for Children´s Interstital Lung Disease
Actual Study Start Date : December 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Primary Outcome Measures :
  1. Included subjects with specific diagnosis [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Survial [ Time Frame: 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
400 prevalent patients with childhood interstitial lung disease (chILD) in Europe 100 incident chILD cases per year

Inclusion Criteria:

  • all children with suspected or
  • verified diagnosis of ILD or
  • masquerading as ILD and
  • those with rare localized parenchymal lung diseases

Exclusion Criteria:

  • other indication as inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852928

Contact: Matthias Griese, Prof. +49/89/440057871 Matthias.Griese@med.uni-muenchen.de
Contact: Meike Hengst, Dr. med. +49/89/440057878 Meike.Hengst@med.uni-muenchen.de

Université Pierre et Marie Curie Not yet recruiting
Paris, France, 75571
Contact: Annick Clement, Prof    +33-1 44 73 66 68    annick.clement@aphp.fr   
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Nicolaus Schwerk, MD    +49 (0) 511 5329 ext 138    schwerk.nicolaus@mh-hannover.de   
Contact: Martin Wetzke, MD    +49 (0) 511 5329 ext 138      
University of Padova Recruiting
Padova, Italy, 35128
Contact: Deborah Snijders, Dr    +39 049 821 8015    deborah.snijders@sanita.padova.it   
Hacettepe University, Medical Faculty Recruiting
Ankara, Sihhiye, Turkey, 06100
Contact: Nural Kiper, Prof    +903123051224    nkiper@hacettepe.edu.tr   
Contact: Nagehan Emiralioglu, Dr.    +903123051334    nagehan.emiralioglu@hacettepe.edu.tr   
United Kingdom
University of Edinburgh Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Steve Cuningham, Dr.    +441315360640    steve.cunningham@nhs.net   
Contact: Morag MaClean    +44131 537 3846 / 3878    chILD-UK@ed.ac.uk   
Sponsors and Collaborators
Matthias Griese
Study Chair: Matthias Griese, Prof. Klinikum der Universität München, Dr. von Haunersches Kinderspital
Principal Investigator: Steve Cunningham, Dr. University of Edinburgh

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthias Griese, Prof. Dr. med., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02852928     History of Changes
Other Study ID Numbers: chILD-EU
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthias Griese, Ludwig-Maximilians - University of Munich:

Additional relevant MeSH terms:
Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pulmonary Fibrosis
Lung Diseases, Interstitial
Pulmonary Alveolar Proteinosis
Pulmonary Eosinophilia
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Leukocyte Disorders
Hematologic Diseases
Hypereosinophilic Syndrome